BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6713388 · Received July 14, 2017

    Report

    Report Number
    3013394970-2017-00161
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    June 7, 2017
    Report Date
    July 14, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    05414734004992
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIOSEAL STS PLUS WAS RETURNED FOR EVALUATION OR TERUMO MEDICAL CORPORATION AT (B)(4). THE CARRIER TUBE ASSEMBLY WAS RETURNED MATED WITH THE HEMOSTASIS SHEATH AND WAS RETURNED IN FULL REAR LOCK POSITION. THE ANCHOR WAS NOT POSTED BUT THE DISTAL TIP OF THE ANCHOR WAS VISIBLE AT THE TIP OF THE HEMOSTASIS SHEATH. AN ARTERIOTOMY LOCATOR WAS RETURNED AS WELL. THERE WAS SIGNIFICANT DRIED BLOOD LIKE SUBSTANCE OBSERVED IN AND AROUND THE CARRIER TUBE. FOR FUNCTIONAL TESTING, THE DEPLOYMENT SLEEVE WAS ATTEMPTED TO BE MOVED INTO THE FORWARD LOCK POSITION BUT DUE TO EXCESSIVE DRIED BLOOD LIKE SUBSTANCES IT KINKED DURING THE PROCESS BEFORE THE ANCHOR COULD BE RELEASED THUS NO FUNCTIONAL TESTING WAS POSSIBLE. THE ANCHOR WAS MANUALLY EXTRACTED TO REVEAL COLLAGEN, GREEN TAMPER TUBE AND REMAINING SUTURE. THE COLLAGEN HAD EXPANDED AND DRIED DUE TO EXPOSURE TO BODILY FLUIDS AND MOISTURE; AND WAS STUCK ON THE CARRIER TUBE. NO ANOMALIES WERE FOUND IN THE INTERNAL COMPONENTS. THE SHEATH INNER DIAMETER WAS MEASURED TO BE 0.095". THE CARRIER TUBE OUTER DIAMETER WAS FOUND TO BE 0.0796" AND THE TAMPER TUBE OUTER DIAMETER WAS FOUND TO BE 0.0600". ALL MEASUREMENTS CONFIRMED TO MEET MANUFACTURER SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE ANGIO-SEAL SUTURE PULLED OUT OF THE PATIENT, LEAVING NOTHING TO TAMPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DR. REPORTED HE WAS UP TO THE FINAL STEP OF DEPLOYING THE ANGIOSEAL; HE WAS GOING TO TAMPER THE PLUG; THE WHOLE SUTURE PULLED OUT OF THE PATIENT; THERE WAS NOTHING LEFT TO TAMPER; THERE WAS NO RESISTANCE FELT; HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE; NO COMPLICATIONS WERE NOTED; IT WAS REPORTED THE ANGIOSEAL WAS DEPLOYED USING THE CORRECT TECHNIQUE AND NOTHING UNTOWARD WAS NOTED IN THE PRECEDING STEPS; THERE WAS NO ESTIMATED BLOOD LOSS; AND THE PATIENT IS REPORTED TO BE STABLE AND WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496006 6F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 5842127 05414734004992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention